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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016000612) on 01-FEB-2016. This case was received from a consumer through health authority in a foreign country on 27-01-2016 under CA reference number: IE-HPRA-2016-025747. Initial report was received by the HRPA on 13/Jan/2016 from a member of the public which concerns a 14 year old (also reported as 12-year old) female patient who experienced syncope, fatigue, dizziness, abdominal pain and epistaxis following vaccination with GARDASIL. Concomitant medications: BOOSTRIX on 30/Mar/2012 with dose 3 of GARDASIL. Medical history/concurrent conditions: None reported. The patient was vaccinated with three doses of GARDASIL between 19/Sep/2011 and 30/Mar/2012 (batch number NP26080 (lot number NM26350, expiration date: 31-MAR-2013), lot/batch number G005669, expiration date: 31-JUL-2013 & G014520). After internal review the GARDASIL batch numbers G005669 & G014520 were corrected accordingly. (dose 1: NP26080/dose 2: G005669/dose 3: G014520). On 30/Sep/2013, the patient experienced fainting, chronic fatigue, lightheadedness, tummy pain and excessive nose bleeds that were all ongoing at the time of reporting. The reporter indicated that the patient''s fatigue may have began in Jun/2013, but as the patient was on school holidays, the long sleeps went mostly unnoticed. Corrective treatment included tests unspecified. At the time of reporting the patient was not recovered. Lot number G014520 is an invalid lot number for GARDASIL.
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